Quality audits and internal quality reviews MCQs With Answer

Introduction

Quality audits and internal quality reviews are essential components of pharmaceutical quality assurance for B.Pharm students. These processes evaluate compliance with GMP, SOPs, regulatory requirements and data integrity, identify audit findings, and drive CAPA (Corrective and Preventive Action). Understanding audit types, checklists, sampling, root-cause analysis, audit reports and follow-up helps students prepare for real-world internal audits, supplier assessments and regulatory inspections. This topic covers systematic audit planning, risk-based review, documentation control, auditor competencies and effective reporting. Mastery of these concepts strengthens quality culture and prepares future pharmacists for roles in QA/QC and regulatory affairs. ‘Now let’s test your knowledge with 30 MCQs on this topic.’

Q1. What best describes a quality audit in the pharmaceutical industry?

• A routine manufacturing activity to increase production output
• A systematic, independent and documented process to obtain audit evidence and evaluate it objectively
• A financial review of department budgets
• An ad hoc meeting to discuss new product ideas

Correct Answer: A systematic, independent and documented process to obtain audit evidence and evaluate it objectively

Q2. Which of the following is the primary purpose of an internal quality review?

• To certify suppliers for international trade
• To evaluate internal systems for compliance with SOPs, GMP and regulatory requirements
• To advertise the company products to customers
• To train marketing staff in quality terms

Correct Answer: To evaluate internal systems for compliance with SOPs, GMP and regulatory requirements

Q3. Which of these is NOT a typical type of audit in pharmaceutical quality management?

• First-party (internal) audit
• Second-party (supplier) audit
• Third-party (external/regulatory) audit
• Market-share audit

Correct Answer: Market-share audit

Q4. A first-party audit is best defined as:

• An audit conducted by an independent government inspector
• An audit performed by the organization on its own processes
• An audit conducted by a customer of the organization
• An audit by a certification body for ISO

Correct Answer: An audit performed by the organization on its own processes

Q5. What is the main function of a quality audit checklist?

• To provide a fixed script for auditors to read verbatim
• To guide audit activities by listing requirements, evidence to review and areas to inspect
• To replace audit reports entirely
• To train production staff in manufacturing techniques

Correct Answer: To guide audit activities by listing requirements, evidence to review and areas to inspect

Q6. CAPA in the context of audits stands for:

• Corrective and Preventive Action
• Check, Approve, Plan, Act
• Compliance and Product Assessment
• Control and Production Agreement

Correct Answer: Corrective and Preventive Action

Q7. In audit terminology, a ‘nonconformity’ refers to:

• A compliment about good practices
• A deviation from specified requirements identified during audit
• A planned improvement action
• An informal observation that requires no documentation

Correct Answer: A deviation from specified requirements identified during audit

Q8. Which classification typically indicates the highest level of risk in audit findings?

• Minor
• Major
• Critical
• Informational

Correct Answer: Critical

Q9. Which root cause analysis tool is commonly used in quality investigations?

• SWOT analysis
• 5 Whys
• PESTLE
• Porter’s Five Forces

Correct Answer: 5 Whys

Q10. Objective evidence in an audit refers to:

• Auditor opinions summarized in meeting minutes
• Any verbal assurance from staff
• Records, observations and documents that support findings
• Publisher advertisements about a product

Correct Answer: Records, observations and documents that support findings

Q11. Which of the following is a key element to include in an audit report?

• List of employee salaries
• Detailed findings with objective evidence, severity classification and recommended actions
• Company marketing strategy
• Only positive observations without deficiencies

Correct Answer: Detailed findings with objective evidence, severity classification and recommended actions

Q12. Data integrity principle ALCOA stands for which of the following correct component set?

• Attributable, Legible, Contemporaneous, Original, Accurate
• Available, Linked, Correct, Organized, Archived
• Authentic, Localized, Certified, Observable, Accountable
• Accessible, Logged, Configured, Optimized, Archived

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate

Q13. Which practice is essential for document control in an internal quality review?

• Allowing uncontrolled copies to circulate freely
• Maintaining a master controlled version and a revision history
• Removing revision dates from SOPs to avoid confusion
• Keeping obsolete documents active for day-to-day use

Correct Answer: Maintaining a master controlled version and a revision history

Q14. Supplier qualification in pharmaceuticals usually includes which activity?

• Only reviewing brochures provided by the supplier
• Conducting supplier audits, reviewing quality agreements and performance data
• Letting procurement decide without QA input
• Accepting any supplier that offers the lowest price

Correct Answer: Conducting supplier audits, reviewing quality agreements and performance data

Q15. Which of the following best describes an observation (minor finding) during an audit?

• A documented breach causing product recall
• A noteworthy issue that does not immediately affect product quality but needs correction
• A critical regulatory violation
• A formal warning from the inspectorate

Correct Answer: A noteworthy issue that does not immediately affect product quality but needs correction

Q16. The role of the Quality Unit during an internal audit is to:

• Act as lead auditor for manufacturing operations without independence
• Organize and oversee audit planning, review findings, and ensure CAPA effectiveness
• Only approve invoices for audit expenses
• Run production shifts during the audit

Correct Answer: Organize and oversee audit planning, review findings, and ensure CAPA effectiveness

Q17. Which activity should follow identification of a nonconformity in an audit?

• Immediate deletion of related records
• Initiation of CAPA with root cause analysis and corrective action plan
• Hiring new staff without investigation
• Ignoring minor issues until next audit

Correct Answer: Initiation of CAPA with root cause analysis and corrective action plan

Q18. Risk-based auditing means:

• Auditing only high-revenue processes
• Prioritizing audit resources to areas with greatest risk to product quality and patient safety
• Using random topics unrelated to quality
• Auditing strictly on calendar dates regardless of risk

Correct Answer: Prioritizing audit resources to areas with greatest risk to product quality and patient safety

Q19. Which document often serves as evidence of training effectiveness during an internal quality review?

• Employee birth certificates
• Training records, competency assessments and attendance registers
• Marketing brochures
• Vendor catalogs

Correct Answer: Training records, competency assessments and attendance registers

Q20. An audit trail in a computerized system is important because it:

• Provides a history of changes, who made them and when, supporting data integrity
• Allows anyone to alter results without record
• Is optional and rarely used in regulated environments
• Duplicates paper records unnecessarily

Correct Answer: Provides a history of changes, who made them and when, supporting data integrity

Q21. Which of the following is critical for auditor competence?

• Only having production experience with no GMP knowledge
• Understanding GMP, audit techniques, product processes and effective communication skills
• Being a relative of senior management
• Relying solely on a checklist without training

Correct Answer: Understanding GMP, audit techniques, product processes and effective communication skills

Q22. During an internal audit, confidentiality is maintained by:

• Sharing audit findings publicly on social media
• Limiting distribution of audit reports and storing sensitive information securely
• Discussing results casually in public areas
• Giving full copies of audit files to all employees

Correct Answer: Limiting distribution of audit reports and storing sensitive information securely

Q23. What is the difference between a regulatory inspection and an internal audit?

• Inspections are informal; internal audits are formal
• Regulatory inspections are conducted by authorities and can lead to enforcement actions, while internal audits are internal checks for improvement
• Inspections never review documents
• There is no difference

Correct Answer: Regulatory inspections are conducted by authorities and can lead to enforcement actions, while internal audits are internal checks for improvement

Q24. When planning an internal audit, sampling of records and batches should be based on:

• Random selection without any rationale
• Risk, criticality of process and past performance
• Only the newest records
• Employee preferences

Correct Answer: Risk, criticality of process and past performance

Q25. Change control is important in quality reviews because it:

• Allows uncontrolled changes to speed up production
• Ensures systematic evaluation, approval and documentation of changes affecting product quality
• Is only required for major equipment purchases
• Is a marketing term unrelated to quality

Correct Answer: Ensures systematic evaluation, approval and documentation of changes affecting product quality

Q26. Trend analysis during internal quality review helps to:

• Obscure recurring problems
• Identify patterns in deviations, complaints or test failures for preventive action
• Record only successful batches
• Eliminate the need for CAPA

Correct Answer: Identify patterns in deviations, complaints or test failures for preventive action

Q27. Who is typically responsible for implementing corrective actions after an audit?

• The auditor exclusively
• The process owner or responsible department with QA oversight
• The external regulatory body
• Customers

Correct Answer: The process owner or responsible department with QA oversight

Q28. Which of the following is considered objective evidence that an audit finding has been corrected?

• A verbal statement by staff during closing meeting
• Updated records, revised SOPs and verification records showing effectiveness
• An email congratulating the team
• Anticipated plans without implementation

Correct Answer: Updated records, revised SOPs and verification records showing effectiveness

Q29. A follow-up audit is performed to:

• Verify closure and effectiveness of corrective and preventive actions
• Replace the initial audit report entirely
• Reduce paperwork by ignoring previous findings
• Promote staff without evaluations

Correct Answer: Verify closure and effectiveness of corrective and preventive actions

Q30. What is a commonly recommended minimum frequency for internal quality audits in a pharmaceutical site?

• Every 10 years
• Annually, with risk-based adjustments as needed
• Only once during company formation
• Weekly for all departments regardless of risk

Correct Answer: Annually, with risk-based adjustments as needed

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com